A. Field of the Invention
This invention relates, in general, to volatile skin sanitizing/sterilizing agents, such as isopropyl alcohol, which are commonly applied to patients' skin surfaces by licensed healthcare professionals and by patients themselves, in order to render such skin surfaces medically safe for the hypodermic administration of injectable medicines. These agents are typically applied to skin surfaces in preparation for the administration of injectable medicines such as vaccines and antibiotics, and in preparation for the self-administration of medicines by patients such as those who self-administer insulin.
The present invention relates, in particular, to the incorporation of one or more non-volatile ingredients into such volatile skin sanitizing/sterilizing agents, thereby enabling such ingredient-enhanced agents to form a uniformly-deposited, post-evaporation layer or coating comprised of the said non-volatile ingredients, on the skin surfaces of the hypodermic injection sites to which the said ingredient-enhanced agents are applied. The present invention offers significantly improved efficacy in comparison to the skin sanitizing/sterilizing agents of the relevant prior art, by virtue of the attributes of the said non-volatile ingredients comprising its said thin, deposited layer or coating.
It is medically obvious that the injection of medicines through any un-sanitized areas of skin always presents the substantial risk of inoculating patients with pathogenic microorganisms and microscopic parasites which may reside in the local environment and/or on patients' skin surfaces at such injection site areas. Such microorganisms have the potential to cause very serious, long-term, debilitating, and even life-threatening systemic infections, especially when introduced in such a direct manner. If some patients are inadvertently inoculated with microorganisms which cause communicable diseases, the spread of such diseases through a population can be significantly accelerated.
In stark contrast to the present invention, the skin sanitizing/sterilizing agents which are disclosed in relevant prior art, when applied to a hypodermic injection site, may unwittingly be unevenly and/or incompletely applied thereto, thereby potentially forming undetectable, inadequately sanitized/sterilized gaps within the skin injection site areas treated with such antiquated agents. This increases the potential for the inadvertent injection of medicines through such undetectable gaps, which significantly increases patients' risk of being systemically inoculated with infectious microorganisms.
Prior art discloses so-called “alcohol wipes” or “alcohol swabs” which are saturated with 70% isopropyl alcohol, or, which may be saturated with one or more other, functionally similar, skin sanitizing/sterilizing agents. The said “alcohol wipes” or “alcohol swabs” are currently the most common and widely used means for skin injection site preparation. Skin sanitizing/sterilizing agents of the prior art, such as 70% isopropyl alcohol, are clear and evaporate without a trace almost immediately after their application to a hypodermic injection site. This makes it difficult, if not impossible, for an administrator of injectable medicines to identify the boundaries of, and to verify the continuity-of-sanitization of the treated site of injection, because the sanitizing/sterilizing reagent has evaporated without a trace and may or may not have been uniformly applied to the injection site prior to the injection of such medicines. Under such circumstances, hypodermic injections may also be inadvertently given through completely untreated areas of skin lying outside of the treated skin areas. This is medically unsafe and unacceptable.
The present invention discloses means for ensuring the continuity-of-sanitization at pre-treated skin injection sites, this being of prime medical importance, because when such sites are treated with the said sanitizing/sterilizing solution/suspension/slurry comprising the present invention, the presence of the said thin, deposited layer or coating prevents any un-sanitized or under-sanitized gaps from escaping visual detection within the confines of such treated skin injection site areas. Use of the present invention prevents the administrators of injectable medicines from unintentionally administering injections through undetected, un-sanitized or under-sanitized gaps which can occur within such treated skin injection site areas, and ensures that such injections are given only through uniformly sanitized/sterilized skin injection site areas. One or more blood coagulants are included in the said sanitizing/sterilizing solution/suspension/slurry comprising the present invention and are deposited as a component of the said thin, deposited layer or coating, in order to: enhance the visibility of hypodermic needle puncture entry wounds; reduce bleeding from such puncture wounds; and, to reduce the generation of infectious medical waste associated with the administration of such injections.
The present invention resolves the very serious medical inadequacies inherent in the use of the antiquated means disclosed in the prior art, by enabling the administrators of injectable medicines to visually locate and identify such treated skin injection site areas with the naked eye, and to qualitatively evaluate them for their continuity-of-sanitization.
This is accomplished by their visual examination of the uniformity of the coloration of the said thin, deposited layer or coating, for either the absence of, or the presence of any untreated or under-treated gaps within the boundary of the said deposited layer or coating. The absence of such gaps indicates that such an injection site has been uniformly sanitized/sterilized, and that an injection may be safely administered through the said deposited layer at such an injection site. The presence of one or more such gaps indicates that: the said injection site was inadequately prepared and has not been uniformly sanitized/sterilized; and, that it must therefore be re-treated and visually re-evaluated before an injection can be safely administered through that injection site. If such gaps are detected, the pigment/tint/dye/colorant-enhanced, body-fluid-reactive, blood coagulant-enhanced, skin injection site sanitizing/sterilizing solution/suspension/slurry of the present invention is easily re-applied until the said deposited layer becomes uniform in its consistency and coloration, thereby ensuring: the continuity-of-sanitization at the said injection site; the uniformity of the said deposited layer; and, the safe injection of medicines through such a uniformly sanitized/sterilized skin injection site area. This enables the administrators of injectable medicines to significantly reduce their patients' risk of acquiring potentially serious infections consequent to the administration of injectable medicines, thereby improving both the safety of administering hypodermic injections and the overall quality of their patients' health.
The exclusive and widespread use of the pigment/tint/dye/colorant-enhanced, body-fluid-reactive, blood coagulant-enhanced, skin injection site sanitizing/sterilizing solution/suspension/slurry comprising the present invention will ensure continuity-of-sanitization at skin injection site areas for all patients receiving hypodermic injections, and will greatly decrease their risk of inadvertently acquiring local and/or systemic infections as a consequence of receiving injectable medicines. The reduction of this risk is highly significant when seen in the context of the many millions of injections and immunizations which are administered annually on a global scale, and the importance of potentially reducing this risk on such a grand scale is exponentially magnified. This is especially true for injections and immunizations which are administered in the field, in remote, rural locations where sanitation is limited or non-existent, both here and abroad.
In one or more of the preferred embodiments of the present invention described below, at least two means are disclosed for precisely locating the entrance wound opening of a post-injection needle puncture wound, even when only miniscule oozing of blood and body fluids occurs. One of these means involves the physical and/or chemical reactions which occur when the said pigment/tint/dye component comprising the said thin, deposited layer or coating becomes progressively exposed to the blood/body fluids as they progressively ooze from the post-injection, needle puncture wound entrance. As the said layer or coating adjacent to the said wound entrance becomes progressively exposed to the said oozing blood/body fluids, it becomes progressively discolored, thereby forming a highly visible, progressively-expanding ring of discoloration which encircles, and identifies the location of, the said wound entrance. Another of these means involves the further enhancement of post-injection, needle puncture wound visibility via blood clot formation at the said needle puncture wound's surface opening. Blood clotting at the said needle puncture wound entrance is induced by the blood coagulant ingredient present in the said deposited layer or coating. As the said layer or coating adjacent to the said wound entrance becomes progressively exposed to the said oozing blood/body fluids, its blood coagulant ingredient also becomes progressively exposed to the said oozing blood/body fluids, thereby initiating blood clot formation at the said needle puncture wound entrance. The coloration and physical appearance of the blood clot thus formed, demarcates the said needle puncture wound entrance in and of itself, and its visible presence simultaneously contributes to the visibility and location of the said wound entrance as stated in the previously-cited means.
The present invention improves on the art by preventing the proliferation of diseases acquired as an unintended consequence of receiving injectable medicines and vaccines, and as an unintended consequence of accidental exposure to infectious medical waste associated with excessive injection site bleeding.
A. Description of the Related Art
U.S. Pat. No. 8,269,058; McCarthy, et al.; The authors disclose an absorbable tissue dressing assembly having a sponge-like, chitosan matrix structure and a woven nano-fiber and/or micro-fiber backing material, possessing different colors, “to facilitate identification by a caregiver”. Patches of this dressing assembly are applied internally to achieve hemostasis during surgical operations. Clot formation is achieved by the attraction of the negatively charged red blood cell membranes to the positively-charged surface of the chitosan matrix. In the present invention, blood clot formation also occurs at post-injection hypodermic needle puncture wounds, both by muco-adhesive adsorption of the oozing red blood cells by the chitosan in the said deposited layer, and by physiologically-related clotting mechanisms. However, the present invention utilizes such clot formation to visually identify and locate the said needle puncture wound to facilitate its accurate bandaging. The McCarthy, et al. disclosure does not cite, contemplate or anticipate the utilization of clotting as means to locate a post-injection hypodermic needle puncture wound, and no reference of any kind is made in the authors' text or claims pertaining to any aspect of the present invention.
U.S. Pat. No. 8,236,781, Laugier, et al.; The authors disclose a hydrogel comprised of chitosan carboxyalkylamide, several forms of which are applied into or (as a protective coating) onto burn wounds of varying degrees of severity. The pH of their chitosan variant is adjusted to approximate the pH of human skin, yet is capable of gel formation and works equally well in a dried form when directly applied onto or into such burn wounds. The addition of “colorants” to the authors' chitosan variant is cited only once, at the bottom of their page 7, in brief reference which does not disclose purpose, nor is the use of “colorants” cited in their claims. No other reference of any kind is made in the authors' text or claims pertaining to any aspect of the present invention. The Laugier, et al. disclosure does not cite or contemplate their chitosan variant's ability to: coagulate blood at a wound site; physically and/or chemically react with the blood/body fluids which ooze from hypodermic needle puncture wounds in order to produce a visually-detectable localized color change at the surface opening of such wounds; or, to mask local skin blemishes (such as freckles) existing beneath a prepared hypodermic injection site in order to facilitate the identification, location and proper bandaging of post-injection hypodermic needle puncture wounds. Laugier, et al. also disclose a hydrogel comprised of chitosan carboxyalkylamide which is dehydrated to form a powder. This form of chitosan is included by reference, as an ingredient in at least one of the said non-volatile components comprising the present invention.
U.S. Pat. No. 8,231,893; Carlucci, et al.; The authors disclose a chitosan variant which is utilized to coat an inert, particulate carrier material, which in turn, is then “incorporated into an absorbent structure”, such as a disposable diaper or wipe. This coated article performs absorption of liquids and is not involved in transferring chitosan onto a secondary surface, such as a hypodermic skin injection site. No reference of any kind is made in the authors' text or claims pertaining to any aspect of the present invention. Carlucci's chitosan-coated material is cited as performing gelification and absorption of blood and menses, rather than augmenting natural clot formation at a hypodermic needle puncture wound site, thereby further distinguishing Carlucci from the present invention. Carlucci, et al.,'s use of chitosan does not involve inherent physiological clotting mechanisms. The altered form(s) of chitosan disclosed by Carlucci, et al., is not cited as possessing any coagulative properties, and such coagulative properties are not represented in their disclosure.
U.S. Pat. No. 8,304,595; Daniels, et al.; Nov. 6, 2012; The authors recite the formulation of nanostructures comprised of various materials such as chitosan microparticles which are used to coat a variety of substrate materials in order to provide enhanced hemostasis for bandages, etc. These coated substrate materials are applied to various wounds to induce improved hemostasis. The authors do not disclose the use of their substrate materials as means to transfer their coagulant materials from their substrate materials to a secondary surface, such as a skin hypodermic injection site.
U.S. Pat. No. 6,762,336, MacPhee, et al.; disclose a hemostatic sandwich bandage for application to a variety of wounds, including external skin wounds. The authors do not disclose the use of their bandage as means to transfer their coagulant materials to a secondary surface, such as a skin hypodermic injection site.
U.S. Pat. No. 4,616,644, Saferstein, et al.; The authors disclose an adhesive bandage having a coating of polyethylene oxide which reacts with blood proteins: prothrombin and plasma fibrinogen to increase the rate of hemostasis at a wound site. The authors do not disclose the use of their bandage as means to transfer their coagulant materials to a secondary surface, such as a skin hypodermic injection site.
U.S. Pat. No. 6,267,976; Barnhart, et al.; 424/401, 514/844; In reference to surfactant cleaners of the prior art, Barnhart states, in his “BACKGROUND OF THE INVENTION”, that “dyes were needed in the in the surface cleaner to visually determine and insure that a particular surface had been contacted by the cleaner and disinfectant.” He states that “U.S. Pat. Nos. 4,965,063, 5,110,492, 5,057,303, and 5,064,635 all describe overcoming this problem by providing a cleaning composition for surfaces having a pH sensitive dye which includes a germicide and disappears upon exposure to air”, and that “such a pH sensitive dye might be useful in a surface cleanser, it is not particularly useful in a skin cleansing composition” “since the dye would disappear before it was dispensed.” He further states that “if the user did not remove all of the cleaner from the surface however, a colored residue would still remain.” Barnhart also states that photosensitive dyes “have commonly been used to determine whether a product has been exposed to light so as to warn the user of a particular hazard.” In his “PREFERRED EMBODIMENT FOR CARRYING OUT THE INVENTION” Barnhart specifically states that “Dyes of the type utilized in the skin cleansing compositions of the present invention are added essentially for the aesthetic effect they create in producing a colored product, not for any cleansing properties associated therewith.” Clearly, Barnhart's inclusion of such dyes is not intended for use in the demarcation of a site on the skin intended for the injection of a medicine or vaccine, as is the case in the present invention, nor is any suggestion for such usage mentioned in his text. Photosensitive dyes such as those which are cited as examples in Barnhart, specifically D&C Red No. 28 and Blue No. 1, may be suitable as skin demarcation agents in the present invention, owing to their unique properties as cited in Barnhart. The thin layering of dye utilized in the present invention can also considerably reduce the time intervals required for photo decolorization to take place as opposed to those times cited in Barnhart under his “TABLE II COLOR FADING PROPERTIES OF SAMPLE COMPOSITIONS” section. Barnhart states that non-photosensitive dyes may also be used.
U.S. Pat. No. 4,838,854; Kuzmanovich; 604/506; 604/116, pertains to marking the skin with a non-sterile “opaque” liquid and then “sterilizing” the skin area prior to injection. Kuzmanovich does not disclose any physical and.or chemical reactions taking place between his marking substance and the blood/body fluids which ooze from a hypodermic needle puncture wound. The use of the term “sterilization” is incorrect, since sterility of injection sites cannot be guaranteed, and since some organisms are not affected by the agents used for such “sterilization”, and can therefore be introduced sub-dermally during an injection. The container harboring the said “opaque” liquid is unsanitary, and can become increasingly contaminated by micro organisms after repeated use, thus making this device hazardous to the public health. The application of a dot of the “opaque” liquid does not enable the person giving the injection to accurately determine whether or not the entire affected area of skin has been completely sanitized.
U.S. Pat. No. 8,193,325; Chou, et al.; The authors disclose a processing method for producing nano-particulate chitosan for use in medical applications and other uses. Although Chou, et al. disclose their “nano-miniaturized chitosan” as being “blended to develop antiseptic wound dressing and novel textile as well as cosmetological products such as fiber, non-woven, medical dressing, dress, fabric, cosmetic skin mask and the like, wherein the molecular weight of said nano-miniaturized chitosan is less than 50 k.”, and further, that this form of chitosan is “being further introduced into the fiber manufacturing process with Dry-jet Wet Spinning method to manufacture desired fiber fabric having features of enhanced antiseptic, moisture-retentive and deodorizing capabilities”, Chou, et al. do not contemplate, disclose, or claim simple adsorption onto their fabric surface for purposes of topical application to, and visual demarcation of skin injection sites. One of Chou's cited references pertains to the “Decolorization of Chitosan by Ozone Treatment” (first reference listed), which is not a desirable attribute within the context of the present invention. In passing, Chou, et al. do refer to the use of their form of chitosan as a “cosmetic skin mask”, but this has no relevance in relation to the visual demarcation of skin injection sites, or in relation to the masking of skin blemishes (such as freckles), to prevent the visual occlusion of hypodermic needle puncture wound openings. Curiously, Chou, et al. do not claim the property of coagulation for their form of chitosan, per se., perhaps because this property may have been diminished by their processes. No reference of any kind is made in the author's text or claims pertaining to any aspect of hypodermic injection site preparation.
International Patent Number: AT499923 (T); (issued Mar. 15, 2011), Stengele, et al., International Classification: A01N31/02; A61K8/34; 8/365; 8/46; 8/49; 8/81, A61Q17/00; European Classification: A61K8/34; 8/365; 8/46F, 8/49C6; 8/81R2, A61Q17/00F; and A01N31/02, “Antiseptic Skin Dye”; For additional reference, this patent is also internationally published as patent numbers: DE102007030416 (A1), EP2011475 (A2, A3, and B1), and as ES2361587 (T3).
Stengele, et al. cite on page 9, that: “The invention is suitable for coloring skin colorants, small and large areas of skin before a surgical or medical treatment, such as before surgery, an injection or a puncture”. “The staining solutions used here may have a disinfecting effect and additional staining of the skin by the medical staff it is possible to make sure that the entire area was disinfected”. Stengele, et al. can clearly be used to demarcate and disinfect a small patch of skin prior to an injection, but its composition is needlessly complex and expensive to mass produce in a form suitable specifically for that purpose. However, their invention does not disclose, nor does it contemplate the use of coagulants in association with the demarcation and disinfection of hypodermic injection sites, or the preparation of skin sites for surgery.
The authors further state that the solution comprising their invention requires at least one additional application in order “to make sure that the entire area was disinfected”. Complete “disinfection”, amounting to sterilization of such a skin area is not fully attainable using such means. At best, a reasonable sanitization of the area can be achieved using such means. Furthermore, Stengele, et al. do not disclose the use of such colorants as means to enable the administrator of such injections to better distinguish an injection puncture wound from surrounding skin blemishes (such as freckles), especially when there is no visible post-injection bleeding or oozing at the injection wound site, as is often the case during the administration of intramuscular and subcutaneous injections. In addition to the initial demarcation and sanitization of a patient's injection site as offered in Stengele, et al., the present invention additionally improves the visibility of post-injection puncture wounds, thereby allowing for more accurate location and bandaging of such puncture wounds, which in turn reduces the potential for later infection of such wounds, and thereby improves the overall health of such patients. Also, Stengele, et al. does not mention or contemplate the coagulation of blood oozing from a needle puncture wound as a means for making such puncture wounds easier to identify and accurately bandage. Stengele, et al. claims the use of triarylmethane dyes, indigo dyes, xanthine dyes, quinophthalone, anthraquinone dyes, quinoline yellow (E104), patent blue V (E131) and or brilliant green BS (E142).
In contrast to the prior art, the present invention offers a number of significant improvements which advance the efficacy of the art, by: preventing unintentional hypodermic injection of medicines through un-sanitized or under-sanitized skin surfaces, thereby protecting patients from becoming inoculated with pathogenic organisms while receiving such injections; significantly improving the visibility of, and, the accurate visual location and bandaging of post-injection needle puncture wounds, thereby further reducing the risk of infection of such wounds; and, by reducing bleeding from such wounds, which, in turn, reduces healthcare worker exposure to blood-borne pathogens and reduces the generation of potentially infectious, biohazardous medical waste.